Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients

NCT01173848 | Terminated Phase 3 Results

• 1 other identifier: Cleveland Clinic
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney disease who are not on dialysis.

Conditions

Chronic Kidney Disease Stage 3 and 4

Keywords

CKD; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Subjects Achieving Normal Vitamin D Levels

  within 24 weeks

Study Arms (2)

Vitamin D2

ACTIVE COMPARATOR

Patients randomized to take vitamin D2

Drug: Ergocalciferol

Vitamin D3

ACTIVE COMPARATOR

Patient's randomized to take Vitamin D3

Drug: Cholecalciferol

Interventions

Ergocalciferol DRUG

1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months

Vitamin D2

Cholecalciferol DRUG

1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months

Vitamin D3

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years
• Chronic kidney disease stage 3-4 (eGFR 15-59 mL/min/1.73m2 body surface area, calculated using the MDRD Study equation GFR calculator)
• Hypovitaminosis D (serum 25OHD \< 31 ng/mL)
• Secondary hyperparathyroidism (Intact PTH \> 70 pg/mL for stage 3, and iPTH \> 110 pg/mL for stage 4)

You may not qualify if:

• Initiation of vitamin D therapy between the time of the lab draw used for screening and the screening process
• History of liver failure
• History of intestinal malabsorption or chronic diarrhea
• Serum calcium level greater than 10.2 mg/dL
• Treatment with an activated vitamin D formulation (calcitriol, doxercalciferol or paricalcitol) within the past 6 months
• Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
• Primary hyperparathyroidism, active of a prior history of such
• Active malignancy excluding basal cell or localized squamous cell skin cancer
• Subject is pregnant (e.g. positive HCG test) or breast-feeding
• Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the treatment phase of the study
• Serum phosphorus level greater than 4.5 or treatment with an oral phosphate binder within the past 6 months
• Treatment with cinacalcet or other calcimimetic within the past 6 months
• Anticipated dialysis within 6 months after randomization
• Inability to swallow tablets
• Known sensitivity, intolerance, or other adverse response to the study drugs which would prevent compliance with study medication

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Ergocalciferols; Cholecalciferol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

Adverse Events were not logged by study arms. Early termination of the study lead to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. James Simon
• Organization: Cleveland Clinic

simonj2@ccf.org

216-445-4891

Study Officials

• James F Simon, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2010
• First Posted: August 2, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 18, 2011
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2013-07

Locations

US (1)